Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566885
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
Real-world Study Assessing Efficacy of TezepeLumaB in Patients With Severe Asthma Regardless of Phenotype in Russia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicentre Single Arm Non-interventional Observational Prospective Study to Assess Demographic Characteristics Burden of Disease and Short-term Patient Reported Outcomes on Symptom Relief in Severe Asthma Patients Aged Older Than 12 Qualifying for Treatment With Tezepelumab in Russia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELBRUS
Brief Summary:
ELBRUS is a 12-month 52-week multi-centre prospective non-comparative and non-interventional observational post-reimbursement real-world evidence study that will assess patient-reported outcomes after tezepelumab treatment initiation in participants with severe asthma in Russia
Detailed Description:
This is a multi-centre retrospective-prospective non-comparative and non-interventional observational cohort study involving primary and secondary data collection within real-world settings of participants who initiate tezepelumab for treatment of severe uncontrolled asthma Participants of the study will be the patients eligible for tezepelumab treatment based on the assessment in accordance with the approved product Summary of Product Characteristics SmPC in Russia The administration of tezepelumab will be independent of this study ie a decision of tezepelumab initiation is based on the physicians choice and regulatory and clinical features not on recruitmentparticipation in the study Tezepelumab is indicated as an add-on maintenance treatment for severe asthma therefore patients will continue background asthma therapy throughout the study irrespective of their decision to participate in this study or not
110 eligible participants of both sexes aged 12 years or older will be treated with tezepelumab available in the market and according to the Russian reimbursement policies in approximately 20 sites In eligible participants who agree to take part in the study the enrolment date is defined as the date of informed consent or assent After enrolment and evaluation of inclusionexclusion criteria study participants will commence tezepelumab treatment as per the physicians decision and following the local product SmPC The index date is defined as the date when participants have received the first dose of tezepelumab The enrolment period is the period between enrolment date and index date Additionally participants may be enrolled in this study up to 4 weeks after the first dose of tezepelumab but no longer to avoid responder bias
Participants will be followed for a maximum period of 52 weeks after index date irrespective of treatment discontinuation Patient-reported outcomes - the primary endpoint ACQ-5 and SNOT-22 will be retrospectively collected during enrolment for all patients ie the most recent available values in the 52 weeks prior to index date and prospectively collected at suggested visits at Weeks 4 12 24 and 52 following index date For patients who initiate treatment after being enrolled into the study the baseline value may be collected prospectively after enrolment before start of treatment
The baseline period is defined as the 52 weeks prior to the index date Outcomes of interest such as severe asthma exacerbations medication use and healthcare resource utilization will be collected during enrolment retrospectively for the baseline period 52 weeks prior to the index date and then prospectively at Weeks 4 12 24 and 52 following index date
Overall expected duration of the study from the first patient inclusion to the last patient last visit is about 2 years or until 110 eligible patients are included to the study and data on these patients are collected whichever occurs first
As an observational this study does not imply any intervention into a routine clinical practice including choice of treatment modality or additional diagnostic methods
110 eligible participants of both sexes aged 12 years or older will be treated with tezepelumab available in the market and according to the Russian reimbursement policies in approximately 20 sites In eligible participants who agree to take part in the study the enrolment date is defined as the date of informed consent or assent After enrolment and evaluation of inclusionexclusion criteria study participants will commence tezepelumab treatment as per the physicians decision and following the local product SmPC The index date is defined as the date when participants have received the first dose of tezepelumab The enrolment period is the period between enrolment date and index date Additionally participants may be enrolled in this study up to 4 weeks after the first dose of tezepelumab but no longer to avoid responder bias
Participants will be followed for a maximum period of 52 weeks after index date irrespective of treatment discontinuation Patient-reported outcomes - the primary endpoint ACQ-5 and SNOT-22 will be retrospectively collected during enrolment for all patients ie the most recent available values in the 52 weeks prior to index date and prospectively collected at suggested visits at Weeks 4 12 24 and 52 following index date For patients who initiate treatment after being enrolled into the study the baseline value may be collected prospectively after enrolment before start of treatment
The baseline period is defined as the 52 weeks prior to the index date Outcomes of interest such as severe asthma exacerbations medication use and healthcare resource utilization will be collected during enrolment retrospectively for the baseline period 52 weeks prior to the index date and then prospectively at Weeks 4 12 24 and 52 following index date
Overall expected duration of the study from the first patient inclusion to the last patient last visit is about 2 years or until 110 eligible patients are included to the study and data on these patients are collected whichever occurs first
As an observational this study does not imply any intervention into a routine clinical practice including choice of treatment modality or additional diagnostic methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None